I-biologics, eyaziwa nangokuthi izidakamizwa eziphilayo noma ama-biologic agents, izivivinyo, izivikelo, nezinqubo zokwelashwa ezakhiwe futhi zenziwa ngezinqubo zezinto eziphilayo ngokusebenzisa imithombo yabantu, izilwane noma izinyoni. Lokhu kuqhathaniswa nezidakamizwa zokwelapha, ezenziwe ezikhathini zamakhemikhali.
Kunanoma iyiphi inombolo yezinto ezithathwe kubantu, izilwane noma ama-microorganisms asetshenziselwa imikhiqizo yezinto eziphilayo, njenge-ushukela, amaprotheni, i-nucleic acid, amaseli, igazi noma ama-tissue.
Ukusebenzisa i-biotechnology, zihlanganisiwe noma zicutshungulwe ukuze zenze izinto ezingasisiza ukuba sihlolisise , siphathe, siphathe, noma siphulukise izifo nemibandela.
Phakathi kwamakhemikhali okuqala e- insulin , okwakusekuqaleni kwawo kwakutholakala ezilwaneni. Imikhiqizo ye-insulin yanamuhla ingaba yimbangela ye-DNA ephindaphindiwe, indlela ehlukile, kodwa imvelo yemvelo.
Imishanguzo yizinto eziphilayo ezitholakale amakhulu eminyaka. Zakhiwa ngokusebenzisa ingxenye yegciwane noma amabhaktheriya abangela isifo esivinjelwe. Lokhu kungaba ukuhlukunyezwa kwegciwane elibulalayo noma eliphansi, noma kungase kube amaprotheni ahlanzekile, ushukela noma enye ingxenye yegciwane.
Ngokumisa umuntu kulokhu kulungiselelwa okwenziwa kusuka kulesigciwane noma amabhaktheriya embuzweni ngaphambi kokuba bagule, umzimba uphendula ngokwakhiwa kwama-antibodies ngokumelene nesifo. Kamuva, uma kuvezwe, isiguli ngeke sihlakulele lesi sifo.
Inqubo yikho konke okuphilayo.
Ezinye izivivinyo ezijwayelekile nezindlela zokwelashwa ziyizinto eziphilayo, futhi. Imikhiqizo yegazi esetshenziselwa ukumpontshelwa , ukuhlolwa okuningi kokungezwani komzimba kanye nokudubula, ukwelashwa kwama-hormonal njengalawo asetshenziselwa ukuphatha izimpawu zokuya esikhathini sokuya esikhathini, kanye neziqu zokwelapha ezisetshenziswa ukufakelwa kabusha noma ukuthuthukiswa kwamanye ama agent we-biologic zibhekwa njengezinto eziphilayo.
Uhlu lwezinto eziphilayo
Ehlanganiswe kusuka eziningana zezinsiza, nansi uhlu oluhle lwezinto eziphilayo:
- imithi
- insulini
- interleukins
- amahomoni okukhula kwabantu
- i-hormone therapies, njengokusebenzisa i-estrogen noma i-testosterone
- ukuvivinya ukuhlola abanakekeli begazi abangenayo i-HIV noma ezinye izinhlaka ezithathelwanayo
- igazi kanye nemikhiqizo yegazi yokumpontshelwa igazi
- igazi nemikhiqizo yegazi esetshenziswa ekukhiqizeni neminye imikhiqizo
- izicucu ze-biologic ezisetshenziselwa ukuthuthukisa kokubili ukuhlolwa kokungezwani komzimba kanye nokudonswa kwamagciwane
- amangqamuzana omuntu kanye nezicubu ezisetshenziselwa ukufakelwa isitshalo (isibonelo, amathonti, i-ligaments, kanye nethambo)
- i-gene (DNA) yezokwelapha (bheka ngezansi *)
- amasosha omzimba (bheka ngezansi *)
Ngayinye yalezi zithengiswa ngaphansi kwegama lomkhiqizo okungase libonakale ngaphezulu, njenge-Avastin, i-Herceptin, i-Enbrel, i-Epotin, i-Remicade, i-Huma noma i-Avonex.
I-Biologics Ayinayo Ngokucacile Izilinganiso Zesizukulwane Esijwayelekile
Ngokungafani nezidakamizwa ezindala zamakhemikhali, ama-biologics amaningi ayinalo okuchazwe ngokucacile njengama- generic equivalent . I-FDA ichaza ama-generics njengendlela yokwenza isithako esiyinkimbinkimbi esifanayo njengomuthi wegama lomkhiqizo. Akukhona lokho kuphela, kodwa futhi banama-bioequivalent - banesimo esifanayo semithi, amandla, ikhwalithi, nokusebenza. Esikhundleni salokho, izibalo zezinto eziphilayo zinezici zemvelo, ezachazwa ngumthetho ngo-2009.
Biosimilars
Ama-Biosimilars yizidakamizwa ezivunyelwe yi-FDA ezingenalo ukuhlukana okunempilo emtholampilo kusuka ku-agent yangempela yegama le-biologic agent.
Kufanele ziphephe futhi ziphumelele futhi zisebenze ngendlela efanayo nomkhiqizo wokubhekisela. Isidakamizwa kuthiwa siyashintshaniswa uma ihlangabezana nesilinganiso sempilo ye-biosimilarity futhi kufanele sikwazi ukushintshwa ngomkhiqizo wokuqala ngaphandle kokukhula engozini.
Imithi yesidakamizwa ye-biosimilar yayigcinwe e-United States kuze kube yilapho kutholakala uMthetho Wokunakekelwa Okunganakekelwa ka-2010. Ngenkathi ye-Biologicals Price Competition ne-Innovation Act (BCPI) ka-2009 kanye noMthetho Wokuvikelwa Kweziguli kanye Nokunakekelwa Okunakekelwayo Kwezimali Zonyaka ka-2010, eziphilayo imikhiqizo inendlela eqondiswayo yokugunyazwa kwelayisense ngokusebenzisa i-FDA.
Izidakamizwa ezengeziwe kanye nezidakamizwa eziguquguqukayo zizotholakala e-United States ngalolu shintsho emthethweni.
Ngaphambi kuka-2009, amaqembu amaningi acele ukugqugquzela i-FDA ukuthi iqale ukuvumela ukukhiqizwa kwezinto eziphilayo noma izinguqulo ezilandelayo ze-biologics endala njengendlela yokulondoloza imali yesistimu yezempilo. Isibonelo, ukubizwa nge-insulin kanye nemikhiqizo yohlobo lwe-insulini kungabiza kusuka ku-$ 150 kuya ku-$ 1000 ngenyanga. Ukulandelana okulinganayo kungahle kudilize u-$ 25 ngenyanga kuphela. Uma kunwetshwa inani labantu abadinga lezi zinhlobo zokwelapha, ungabona ukuthi ukuvunyelwa kwalezi zici ze-biologics kungalondoloza kanjani izigidigidi zesistimu.
Abakhiqizi be-biologic ezinkulu babemelana nokuthuthukiswa nokukhiqizwa kwezinhlobo zezinto eziphilayo ngenxa yokuthi abafuni ukuphoqelela ngemithi engabizi, kodwa ephumelelayo (landela imali). Bakhuluma ngezinkinga zokuphepha kwinqubo yokuthuthukiswa nokuntuleka kobufakazi bokuthi lezi zidakamizwa ziyoba ngempumelelo njengeziqalo.
Umthombo
Ulwazi lwabathengi (i-Biosimilars) - US Ukuphathwa Kwezokudla Nezidakamizwa 8/27/2015.